Enovid, Enovid-E, Enovid-E 21

NDA 10976, held by Gd Searle LLC. Mestranol; Norethynodrel.

As of Nov 13, 2026, NDA 10976 (Enovid, Enovid-E, Enovid-E 21), held by Gd Searle LLC, was first approved by FDA on Mar 9, 1961, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1961
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Mar 9, 1961	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Enovid0.075MG;5MG · tablet;oral-20	Mestranol; Norethynodrel	Discontinued
Enovid0.15MG;9.85MG · tablet;oral	Mestranol; Norethynodrel	Discontinued
Enovid-E0.1MG;2.5MG · tablet;oral-20	Mestranol; Norethynodrel	Discontinued
Enovid-E 210.1MG;2.5MG · tablet;oral-21	Mestranol; Norethynodrel	Discontinued
Enovid0.075MG;5MG · tablet;oral	Mestranol; Norethynodrel	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 23, 1986	Supplement 73Labeling	Approved	None posted
Jun 10, 1986	Supplement 72Labeling	Approved	None posted
Mar 13, 1986	Supplement 71Labeling	Approved	None posted
Jun 5, 1985	Supplement 70Labeling	Approved	None posted
Apr 5, 1985	Supplement 69Labeling	Approved	None posted
Sep 18, 1984	Supplement 68Labeling	Approved	None posted
Mar 6, 1984	Supplement 66Labeling	Approved	None posted
Jun 23, 1983	Supplement 63Manufacturing · Standard review	Approved	None posted
Jun 3, 1983	Supplement 64Manufacturing · Standard review	Approved	None posted
Nov 22, 1982	Supplement 61Manufacturing · Standard review	Approved	None posted
Feb 12, 1981	Supplement 42Labeling	Approved	None posted
Feb 22, 1978	Supplement 53Manufacturing · Standard review	Approved	None posted
Mar 9, 1961	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Identifiers

Application: NDA 10976
Drugs@FDA: Overview at FDA
Company: G.D. Searle

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters